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MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 recallZ-2747-2016 · Mentor Texas, LP. · initiated Aug 9, 2016

Class II Terminated All recalls posted in September 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Mentor Texas, LP. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc

FDA root cause category: Employee error

What the company is doing

The firm, Mentor, sent an "MEDICAL DEVICE REMOVAL" letter dated 8/11/2016 to affected consignees. The letter will be followed up with a respective sales representative visit. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately identify all unused units and return them per the normal return process; forward the letter to anyone your facility that needs to be informed; if you have sent these units to another facility, forward the letter to that facility; and maintain awareness of the letter until all units in your inventory have been returned. If you have any questions, please contact your local Mentor sales representative or Mentor Customer Service at 1-800-235-5731.

Recall details

Recall number
Z-2747-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 9, 2016
Posted by the FDA
Sep 7, 2016
Recalling firm
Mentor Texas, LP.
Quantity
65 units
Product code
LCJ
FDA submissions
K130813
Distribution
Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.

Product description

MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

Code information (models, lots, serial numbers)

Lot 6981537

Other devices under the same FDA submission

34 devices cleared under K130813 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 74895).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page